Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, MD, USA.
Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, MD, USA.
Semin Oncol. 2018 Aug;45(4):201-209. doi: 10.1053/j.seminoncol.2018.06.003. Epub 2018 Oct 25.
Older adults with lung cancer often have comorbidities that may increase risk of symptomatic adverse events (AEs) and physical function decline. The objective of this study was to examine age-related differences in patient-reported symptoms and functional domains in patients with advanced lung cancer receiving immunotherapy drugs.
Three randomized controlled trials of anti-programmed death receptor-1/programmed death-ligand 1 therapy in patients with advanced non-small cell lung cancer that included patient-reported outcomes (PROs) were identified. Baseline PRO data were pooled for treatment arms from 2 trials that included the same PRO tools. Age-related differences in baseline mean scores for each of the health-related quality of life functional and symptom scales were assessed for patients ≥70 years and <70 years. Mean change from Baseline at 3 months was also calculated and plotted for each age group. The adequacy of PRO assessments was assessed by comparing clinician-reported AE data in the 3 trials to the item content of the PRO tools included.
Across the 3 trials, 75 of patients were under 70 and 26% patients were 70 and older. Comparing baseline scores in the 2 trials with the same PRO tool, older adults reported small differences including lower physical functioning, less pain, insomnia and financial difficulties, and higher social functioning than younger patients at baseline. No large differences in the distributions of mean change from baseline in function or symptom were identified. Several common clinician-reported symptomatic AEs were not assessed by the PRO strategy employed in the 3 trials. Three clinician-reported symptomatic AEs (rash, fever, and pruritus) that were commonly reported in the safety data (9%-19%) were not assessed using the PRO tools employed.
While several small differences were seen, there did not appear to be large differences at baseline or in the distributions of change from baseline in PRO functional domains between younger and older patients with lung cancer undergoing anti-programmed death receptor -1/programmed death-ligand 1 therapy. Relevant symptomatic side effects were not assessed by PRO measures in these trials, and this is a limitation of current PRO assessment strategies.
患有肺癌的老年患者通常合并有多种疾病,这可能会增加症状性不良反应(AE)和身体功能下降的风险。本研究旨在探讨接受免疫治疗药物的晚期肺癌患者中,年龄相关的患者报告症状和功能领域差异。
确定了三项针对晚期非小细胞肺癌患者的抗程序性死亡受体 1/程序性死亡配体 1 治疗的随机对照试验,这些试验均包含患者报告的结局(PRO)。从包含相同 PRO 工具的两项试验的治疗组中汇总了基线 PRO 数据。评估了年龄≥70 岁和<70 岁的患者各健康相关生活质量功能和症状量表基线平均得分的年龄相关差异。还计算并绘制了每个年龄组从基线到 3 个月的平均变化。通过将 3 项试验中的临床医生报告的 AE 数据与 PRO 工具中包含的项目内容进行比较,评估了 PRO 评估的充分性。
在 3 项试验中,有 75 名患者年龄<70 岁,26%的患者年龄≥70 岁。比较包含相同 PRO 工具的两项试验的基线评分,与年轻患者相比,老年患者在基线时报告了较小的差异,包括身体功能下降、较少的疼痛、失眠和经济困难,以及较高的社会功能。从基线到功能或症状的平均变化分布中没有发现较大的差异。在 3 项试验中,采用的 PRO 策略并未评估几种常见的临床医生报告的症状性 AE。在安全性数据中(9%-19%)经常报告的三种临床医生报告的症状性 AE(皮疹、发热和瘙痒)未使用采用的 PRO 工具进行评估。
尽管存在一些较小的差异,但在接受抗程序性死亡受体 1/程序性死亡配体 1 治疗的肺癌年轻和老年患者中,从基线到 PRO 功能领域的变化分布中,基线或变化分布中似乎没有较大的差异。这些试验中,PRO 测量未评估相关的症状性副作用,这是当前 PRO 评估策略的一个局限性。